Nucynta ER Side Effects

Generic name: tapentadol

Medically reviewed by Drugs.com. Last updated on Apr 9, 2025.

Note: This document provides detailed information about Nucynta ER Side Effects associated with tapentadol. Some dosage forms listed on this page may not apply specifically to the brand name Nucynta ER.

Applies to tapentadol: oral tablet, oral tablet extended release.

Precautions

It is very important that your doctor check your progress at regular visits, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for any unwanted effects.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Signs of an overdose include: change or loss of consciousness, cold, clammy skin, coughing that sometimes produces a pink frothy sputum, difficult, fast or slow, irregular, shallow, or trouble breathing, increased sweating, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, skin, sleepiness or unusual drowsiness, swelling in the legs and ankles, or yellow eyes..

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the medicines listed above while you are using this medicine.

This medicine may cause some people to become dizzy, lightheaded, faint, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Getting up slowly from a lying or sitting position may also help.

Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.

This medicine may cause a serious condition called serotonin syndrome when taken with certain medicines. Check with your doctor first before you take any other medicines. Call your doctor right away if you have a fever, confusion, restlessness, loss of coordination, or diarrhea.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

Do not change the dose or suddenly Stop taking tapentadol (the active ingredient contained in Nucynta ER) without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, including anxiety, restlessness, fever or chills, joint pain, nausea or vomiting, loss of appetite. runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

For nursing mothers:

• Talk to your doctor if you have any questions about taking tapentadol or about how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Nucynta ER

Some side effects of tapentadol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of Nucynta ER

Along with its needed effects, tapentadol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tapentadol:

Get emergency help immediately if any of the following symptoms of overdose occur while taking tapentadol:

Symptoms of overdose

• change in consciousness
• chest pain or discomfort
• cold, clammy skin
• coughing that sometimes produce a pink frothy sputum
• decreased awareness or responsiveness
• difficult or trouble breathing
• increased sweating
• irregular, fast or slow, or shallow breathing
• lightheadedness, dizziness or fainting
• loss of consciousness
• pale or blue lips, fingernails, or skin
• sleepiness or unusual drowsiness
• swelling in the legs and ankles

For healthcare professionals

Applies to tapentadol: oral tablet, oral tablet extended release.

General adverse events

Adults: The most common adverse reactions included nausea, dizziness, vomiting, constipation, headache, and somnolence.

Pediatric: The most common adverse reactions included vomiting constipation, nausea, pruritus, and pyrexia.^[Ref]

Cardiovascular

• Common (1% to 10%): Hot flush/flushing
• Uncommon (less than 1%): Heart rate increased, heart rate decreased, blood pressure decreased, palpitations
• Frequency not reported: Hypotension or peripheral vasodilation

Hypotension or peripheral vasodilation included orthostatic hypotension and syncope.

Dermatologic

• Common (1% to 10%): Pruritus, hyperhidrosis, generalized pruritus, rash
• Uncommon (less than 1%): Urticaria
• Postmarketing reports: Angioedema

Endocrine

• Frequency not reported: Inhibition of hormone secretions, stimulation of secretions, hypogonadism
• Postmarketing reports: Androgen deficiency, adrenal insufficiency

Inhibition of hormone secretions included inhibition of adrenocorticotropic hormone, cortisol, and luteinizing hormone.

Stimulation of secretions included secretion of prolactin, growth hormone, insulin, and glucagon.

Androgen deficiency included symptoms of low libido, impotence, erectile dysfunction, amenorrhea, and infertility.

Gastrointestinal

• Very common (10% or more): Nausea (up to 30%), vomiting (up to 24.7%), constipation (up to 16.5%; higher rate in older adults)
• Common (1% to 10%): Dry mouth, dyspepsia, diarrhea
• Uncommon (less than 0.1%): Impaired gastric emptying, abdominal discomfort
• Frequency not reported: Spasm of sphincter of Oddi, increased serum amylase, reduced pancreatic secretions

Genitourinary

• Common (1% to 10%): Urinary tract infection
• Uncommon (less than 1%): Urinary hesitation, pollakiuria, sexual dysfunction

Hepatic

• Uncommon (less than 1%): GGT increased, ALT increased, AST increased
• Frequency not reported: Reduced biliary secretions

Hypersensitivity

• Uncommon (less than 1%): Hypersensitivity
• Postmarketing reports: Anaphylaxis, anaphylactic shock

Metabolic

• Common (1% to 10%): Decreased appetite
• Uncommon (0.1% to 1%): Weight decreased

Musculoskeletal

• Common (1% to 10%): Muscle spasms, involuntary muscle contractions
• Uncommon (less than 1%): Sensation of heaviness

Nervous system

• Very common (10% or more): Dizziness (up to 24%), somnolence (up to 15%), headache (up to 10.2%)
• Common (1% to 10%): Tremor, lethargy, disturbance in attention
• Uncommon (less than 1%): Hypoesthesia, paresthesia, sedation, dysarthria, depressed level of consciousness, memory impairment, ataxia, presyncope and syncope, seizure/convulsion, abnormal coordination
• Postmarketing reports: Delirium

Ocular

• Uncommon (less than 1%): Visual disturbance
• Frequency not reported: Red eyes, miosis, mydriasis

Other

• Common (1% to 10%): Fatigue, feeling hot, pyrexia, asthenia, feeling of body temperature change
• Uncommon (less than 1%): Edema, feeling drunk, feeling abnormal, feeling of relaxation
• Frequency not reported: Drug tolerance/reduced drug response, physical dependence

Psychiatric

• Common (1% to 10%): Insomnia/sleep disorder, hallucination, confusional state, abnormal dreams, anxiety, nervousness, restlessness
• Uncommon (less than 1%): Irritability, drug withdrawal syndrome, euphoric mood, disorientation, restlessness, agitation, thinking abnormal, depressed mood
• Frequency not reported: Addiction, neonatal opioid withdrawal syndrome
• Postmarketing reports: Suicidal ideation, panic attack, hyperalgesia, allodynia, serotonin syndrome

Respiratory

• Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, dyspnea
• Uncommon (less than 1%): Oxygen saturation decreased, cough, dyspnea, respiratory depression

See also:

Frequently asked questions

• What does XR or ER mean after a drug name?

Further information

Nucynta ER side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer